Rilpivirine can cause serious, life-threatening side effects. These include depression, mood changes, and liver problems.
Contact your health care provider right away if you have any of the following symptoms of depression or mood changes:
- Feeling sad or hopeless.
- Feeling anxious or restless.
- Having thoughts of hurting yourself (suicide) or have tried to hurt yourself.
Liver problems can happen in people who take rilpivirine. People with a history of hepatitis B virus (HBV) or hepatitis C virus (HCV) infection or who have certain liver function test changes may have an increased risk of developing new or worsening liver problems while taking rilpivirine. Liver problems have also occurred during treatment with rilpivirine in people without a history of liver disease. People taking rilpivirine may need tests to check liver function before and during treatment with rilpivirine.
While taking rilpivirine, it is important to keep all of your appointments with your health care provider.
What is rilpivirine?
Rilpivirine is a prescription medicine approved by the U.S. Food and Drug Administration (FDA) for the treatment of HIV infection in adults who have never taken HIV medicines before and who have a viral load (number of HIV RNA copies per mL of blood) of 100,000 copies/mL or less at the start of treatment. Rilpivirine is always used in combination with other HIV medicines.
Rilpivirine belongs to a class (group) of HIV drugs called non-nucleoside reverse transcriptase inhibitors (NNRTIs). NNRTIs attach to and block an HIV enzyme called reverse transcriptase. (An enzyme is a protein that starts or increases the speed of a chemical reaction.) By blocking reverse transcriptase, NNRTIs prevent HIV from multiplying and can reduce the amount of HIV in the body.
Rilpivirine does not cure HIV/AIDS. People with HIV should stay on continuous HIV treatment as directed by their health care provider and should take steps to avoid passing HIV to others (for example, always using a condom during sex).
What should I tell my health care provider before taking rilpivirine?
Before taking rilpivirine, tell your health care provider:
- If you are allergic to rilpivirine or any other medicines.
- If you have had or currently have liver problems, including HBV or HCV infection.
- If you have ever had a mental health problem.
- If you are pregnant or plan to become pregnant. Whether rilpivirine can harm an unborn baby is unknown.
- If you are breastfeeding or plan to breastfeed. Do not breastfeed if you are infected with HIV or are taking rilpivirine.
- About other prescription and nonprescription medicines, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Rilpivirine may affect the way other medicines or products work, and other medicines or products may affect how rilpivirine works. Taking rilpivirine with certain medicines or products may cause serious side effects.
How should I take rilpivirine?
Rilpivirine comes in tablet form. Each tablet contains 25 mg rilpivirine (brand name: Edurant).
Take rilpivirine according to your health care provider’s instructions.
Always take rilpivirine with a meal. (A protein drink alone does not replace a meal.)
Always take rilpivirine in combination with other HIV medicines.
If you take too much rilpivirine, contact your health care provider or local poison control center (1-800-222-1222) right away or go to the nearest hospital emergency room.
For more information on how to take rilpivirine, see the FDA drug label from DailyMed. (DailyMed is a federal website that includes the most recent drug labels submitted to FDA.)
What should I do if I forget a dose?
If you miss a dose of rilpivirine within 12 hours of the time you usually take it, take your dose with a meal as soon as possible. Then take your next dose at the regularly scheduled time. If you miss a dose by more than 12 hours from the time you usually take it, wait and then take the next dose at the regularly scheduled time.
What side effects can rilpivirine cause?
Rilpivirine can cause serious, life-threatening side effects. These include depression, mood changes, and liver problems. (See the WARNING above.)
Other possible side effects of rilpivirine include:
- Changes in body fat (lipodystrophy).
- Changes in the immune system (immune reconstitution inflammatory syndrome [IRIS]).
Tell your health care provider if you have any side effect that bothers you or that does not go away.
These are not all the possible side effects of rilpivirine. Ask your health care provider or pharmacist for more information on possible side effects of rilpivirine. You may also want to read this fact sheet about HIV medicines and side effects.
You may report side effects to FDA at 1-800-FDA-1088 (1-800-332-1088).
How should rilpivirine be stored?
- Store rilpivirine between 59°F and 86°F (15°C to 30°C).
- Keep rilpivirine in the container that it came in and keep the container tightly closed. The container helps protect rilpivirine from light. If the container has a small packet of drying agent (called a desiccant), do not remove it. The desiccant protects the medicine from moisture.
- Do not use rilpivirine if the original seal over the bottle opening is broken or missing.
- Safely throw away rilpivirine that is no longer needed or expired (out of date).
- Keep rilpivirine and all medicines out of reach of children.
Where can I find more information about rilpivirine?
More information about rilpivirine is available:
Janssen Pharmaceuticals, Inc.
The above Patient Version drug summary is based on the following FDA label(s): Tablet (film coated)
Last Reviewed: February 28, 2014
Last Updated: February 28, 2014